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First-in-Human Study of Bamlanivimab in a Randomized Trial of Hospitalized Patients With COVID-19.
Chen, Peter; Datta, Gourab; Grace Li, Ying; Chien, Jenny; Price, Karen; Chigutsa, Emmanuel; Brown-Augsburger, Patricia; Poorbaugh, Josh; Fill, Jeffrey; Benschop, Robert J; Rouphael, Nadine; Kay, Ariel; Mulligan, Mark J; Saxena, Amit; Fischer, William A; Dougan, Michael; Klekotka, Paul; Nirula, Ajay; Benson, Charles.
Afiliação
  • Chen P; Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
  • Datta G; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Grace Li Y; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Chien J; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Price K; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Chigutsa E; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Brown-Augsburger P; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Poorbaugh J; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Fill J; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Benschop RJ; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Rouphael N; Emory University, Atlanta, Georgia, USA.
  • Kay A; Emory University, Atlanta, Georgia, USA.
  • Mulligan MJ; NYU Grossman School of Medicine, New York, New York, USA.
  • Saxena A; NYU Grossman School of Medicine, New York, New York, USA.
  • Fischer WA; The University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
  • Dougan M; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
  • Klekotka P; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Nirula A; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Benson C; Eli Lilly and Company, Indianapolis, Indiana, USA.
Clin Pharmacol Ther ; 110(6): 1467-1477, 2021 12.
Article em En | MEDLINE | ID: mdl-34455583
ABSTRACT
Therapeutics for patients hospitalized with coronavirus disease 2019 (COVID-19) are urgently needed during the pandemic. Bamlanivimab is a potent neutralizing monoclonal antibody that blocks severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) attachment and entry into human cells, which could potentially lead to therapeutic benefit. J2W-MC-PYAA was a randomized, double-blind, sponsor unblinded, placebo-controlled, single ascending dose first-in-human trial (NCT04411628) in hospitalized patients with COVID-19. A total of 24 patients received either placebo or a single dose of bamlanivimab (700 mg, 2,800 mg, or 7,000 mg). The primary objective was assessment of safety and tolerability, including adverse events and serious adverse events, with secondary objectives of pharmacokinetic (PK) and pharmacodynamic analyses. Treatment-emergent adverse event (TEAE) rates were identical in the placebo and pooled bamlanivimab groups (66.7%). There were no apparent dose-related increases in the number or severity of TEAEs. There were no serious adverse events or deaths during the study, and no discontinuations due to adverse events. PKs of bamlanivimab is linear and exposure increased proportionally with dose following single i.v. administration. The half-life was ~ 17 days. These results demonstrate the favorable safety profile of bamlanivimab, and provided the initial critical evaluation of safety, tolerability, and PKs in support of the development of bamlanivimab in several ongoing clinical trials.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Contexto em Saúde: 4_TD / 6_ODS3_enfermedades_notrasmisibles Problema de saúde: 4_covid_19 / 4_pneumonia / 6_non_migraine_headache / 6_other_respiratory_diseases Assunto principal: Antivirais / Anticorpos Monoclonais Humanizados / COVID-19 / Tratamento Farmacológico da COVID-19 / Hospitalização Tipo de estudo: Clinical_trials Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Pharmacol Ther Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Contexto em Saúde: 4_TD / 6_ODS3_enfermedades_notrasmisibles Problema de saúde: 4_covid_19 / 4_pneumonia / 6_non_migraine_headache / 6_other_respiratory_diseases Assunto principal: Antivirais / Anticorpos Monoclonais Humanizados / COVID-19 / Tratamento Farmacológico da COVID-19 / Hospitalização Tipo de estudo: Clinical_trials Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Pharmacol Ther Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos
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